Current Thinking Behind Decision Making in Oncology Clinical Pathway Design

Rhonda Greenapple, MSPH

The wide variety and high cost of available treatments for patients with cancer can present challenges to clinicians for deciding upon the most appropriate and cost-effective care.1 These challenges will only increase with time because recent data show that there are now nearly 1000 medicines and vaccines in the oncology pipeline.2 Moreover, the cost for currently available cancer medications increased 22.3% in 2012, with utilization increasing 3.4%.3 Genetically targeted therapies represent much of the increase in the cost of cancer medicines. In 2012, specialty conditions accounted for 24.5% of the drug spend in the United States, with many of the 22 new specialty drugs approved that year costing more than $10,000 per month of treatment.2 The increasing number, type, and cost of cancer therapies confront healthcare providers and payers alike with a pressing need for a method to identify the most effective treatments and reduce cancer care–related costs.

Clinical pathways are a means by which clinicians can arrive at appropriate treatment decisions in cancer care and, at the same time, help reduce costly treatment variation and improve quality of care.1 In addition, oncology care providers who adhere to clinical pathways can benefit from financial and administrative incentives offered by payers.4 When pathways were first introduced, however, oncologists were concerned that they would face payer-imposed limitations to exercising their clinical judgment when treating patients.5 Nevertheless, clinical pathways have gained traction in the healthcare marketplace as payers have sought to collaborate with providers in the design and implementation of clinical pathways. Accordingly, physician involvement in the development of clinical pathways is now recognized as critical to their adoption and success.1

Reimbursement Intelligence (RI), a market access consulting firm, completed an online survey in August 2013 of 50 oncology providers representing independent community practices, hospital-affiliated practices, physician network–affiliated practices, and hospitals/academic medical centers. In addition, 20 in-depth interviews were conducted with a subset of respondents responsible for pathway design. The objective was to learn more about the decision-making process in clinical pathway development.

The Model of Cancer Care Is Shifting to Clinical Pathways

The development of clinical pathways can be seen as a shift toward a new model for making cancer care treatment decisions, based on increasingly restrictive decision-making criteria. At the broad end of the decision criteria spectrum, for example, are earlier models such as that used by Medicare. This decision model determines coverage using the compendia of authoritative sources, which determines the level of clinical evidence to support on- and off-label uses of oncology drugs. Somewhat more focused recommendations for treatment, although still broad in nature, are those written by professional societies with National Comprehensive Cancer Network (NCCN) guidelines most prominent. These recommendations are utilized to determine coverage of a product by a private payer. Now, with the advent of clinical pathways, we are seeing highly specific recommendations for patient management being developed by providers for use in their particular organizations.

Pathways are becoming increasingly prevalent, as evidenced by the majority of RI survey respondents reporting that they currently utilize pathways in the treatment of breast, lung, and colorectal cancers.

Oncology Providers Lead the Way in Developing of Pathway Design

There has been an influx of pathway design companies available to assist payers and oncology practices. Pathway companies can track and report utilization and identify benchmarks of adherence to pathways. They can also identify where there may be inappropriate or excessive utilization of treatments and services such as colonystimulating factors and imaging. Survey questions about pathway design showed that 45% of the pathway users developed their own pathways, with the remainder of pathway users receiving pathway design assistance from pathway vendors such as US Oncology and Via Oncology (28% and 14% of users, respectively). This extensive use of pathway design assistance may reflect oncology providers’ ability to customize their pathways even within a system that uses a pathway vendor.

Oncology providers want to make sure the pathways reflect the needs of the patient population within their practice, and many pathway design companies allow some flexibility regarding drugs that are not on pathway. Figure 1 reinforces that oncologists, not payers, are the key players in pathway design. Those who participated in the design of clinical pathways were most often oncologists within the practice (77%), followed by pathway vendors (27%), pharmacists (27%), and payer representatives (15%). Oncologists’ leadership ensures the pathways reflect the latest clinical treatment.

Safety and Efficacy Are Top Considerations for Inclusion of Treatments, Followed by Cost

So how do pathway users decide upon a given treatment regimen versus another in designing a clinical pathway?

In mid-2009, a statewide collaboration between Blue Cross Blue Shield of Michigan (a single-state, not-for-profit BCBS plan), Physician Resource Management (a state physician organization), and Cardinal Health Specialty Solutions (an oncology benefit management company) created a clinical pathway program in which physicians developed the content, structure, and implementation of the program.1 In this program, pathway regimen selections were considered in order of descending priority starting with treatment efficacy, then toxicity, then cost.

Decision making was similar in the 2010 program, a collaboration between Aetna and The US Oncology Care Network, wherein efficacy was given first priority, toxicity was second, and if both efficacy and toxicity were similar, then the lower-cost regimen was preferred for incorporation into the pathway.5

Given that many pathway designers placed safety immediately after efficacy as a consideration in selecting treatment, a natural question arises as to which factors carry the most weight in evaluating the relative safety and tolerability of different drugs being considered for placement on pathways. The RI survey results shown in Figure 2 indicated that clinical trial design was the top safety/tolerability consideration for pathway placement, followed by the amount of time a drug was on the market, and real-world performance of the drug.

Interestingly, the aforementioned 2 successful pathway collaborations reflect trends later identified in the RI survey, which found that clinical data showing clear treatment superiority were most influential on the decision to place a product on pathway for 67% of pathway designers surveyed. Also, Figure 3 shows that if both efficacy and safety of 2 active therapeutics were equivalent, cost then became a consideration for 38% of pathway designers surveyed, and 29% considered cost after efficacy alone was shown to be equivalent. Similar results were found when both efficacy and safety of 2 supportive care agents were equivalent, with cost then becoming a consideration for 48% of pathway designers surveyed, and 24% considering cost after efficacy alone was shown to be equivalent.

It has been well documented that the high cost of cancer care can be an impediment to patients receiving necessary treatment.6,7 Physicians must necessarily be cognizant of expensive costs that might impact their patients’ ability to adhere to treatment. For this reason, cost is becoming an increasingly important consideration in clinical pathway design. The RI survey found that when cost factors became a consideration, drugs costs were ranked as the greatest contributing cost consideration for on pathway placement, followed by overall cost of care, and the cost to patient.

Financial and Administrative Incentives Are Primarily Performance-Based and Tied to Organizations

As previously mentioned, payers are of offering financial and administrative incentives to oncology care providers who adhere to clinical pathways. Examples of such incentives can be found in the pathway collaboration between Blue Cross Blue Shield of Michigan and Oncology Physician Resource, a physician-owned practice management entity. Each oncologist who signed up to use the pathway received a $5000 incentive payment; also, the reimbursement rate for generics was increased, and physicians were promised a certain percentage of any savings related to expenditures for chemotherapy and supportive medications.8

The responses to the RI survey showed that incentives for adherence to clinical pathways were tied to the oncology practice as a whole for 46% of pathway users surveyed, while 29% of pathway users had incentives tied to both the oncology practice as a whole and the individual oncologists in the practice. Figure 4 details the variety of incentives most commonly offered to providers, as indicated by the respondents to the RI survey. Incentives were performance-based in 39% of the organizations surveyed, suggesting that payers and providers place great importance on patient outcomes.

The creation of a case management fee to replace drug margin incentives was found in 25% of provider organizations surveyed. Shared savings between payer and provider was an incentive for 25% of pathway users surveyed, and more generous reimbursement for the use of generics was an incentive for 21% of users. Payer coverage was pre-approved for 18% of provider organizations, essentially creating another incentive: removal of the requirement for prior authorization for on-pathway treatment. Finally, risk-sharing between payer and provider was an incentive among 11% of pathway users.

Summary

Clinical pathways represent a shift in how cancer care decisions are made, moving from the use of general guidelines for providing treatment to more specific considerations based upon efficacy safety, and cost. Pathways utilization is increasing, particularly in the treatment of breast, lung, and colorectal cancer. Pathway design companies can provide assistance in pathway design, monitoring services, and may offer some flexibility to oncologists in making treatment decisions. Oncologists’ buy in is seen as essential to the success of pathways and the primary participants in pathway design are most often the oncologists within the practice adopting the pathway. Participation in pathways is being incentivized by payers who offer incentive payments, increased reimbursement rates, case management fees, shared savings, pre-approved coverage, and risk sharing.

2. Pharmaceutical Research and Manufacturers of America. PhRMA: nearly 1000 medicines in development to help patients in their fight against cancer [press release]. Washington, DC: May 31, 2012. http://www.phrma.org/media/releases/nearly-1000-medicines-developmenthelp-patients-their-fight-against-cancer. Accessed November 30, 2013.